Clinical Trial: Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)

Brief Summary: The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).

Detailed Summary:
Sponsor: Retina Research Institute, LLC

Current Primary Outcome: Safety [ Time Frame: 12 months ]

The Incidence & Severity will be assessed during study participation. Baseline medical conditions & abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.


Original Primary Outcome: Incidence and Severity of Adverse Events [ Time Frame: 12 months ]

All baseline medical conditions and abnormal finding present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit for 12 months, and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.


Current Secondary Outcome:

  • Mean visual acuity (BCVA) at Months 6 and 12 [ Time Frame: Month 6 and Month 12 ]
  • Mean change in OCT central foveal thickness from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  • Mean change in Macular Volume from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  • Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  • Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  • Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12 [ Time Frame: Months 6 and 12 ]


Original Secondary Outcome: Same as current

Information By: Retina Research Institute, LLC

Dates:
Date Received: April 2, 2012
Date Started: June 2012
Date Completion: December 2015
Last Updated: July 24, 2015
Last Verified: July 2015